Application 091289

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091289-001	TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A091289-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091289-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-10-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091289-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091289-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091289-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091289-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091289-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091289-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091289-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091289-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091289-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091289-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091289-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091289-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091289-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091289-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091289-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091289-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091289-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091289-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091289-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091289-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091289-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091289-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091289-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091289-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091289-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091289-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091289-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091289-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091289-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091289-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091289-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091289-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091289-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091289-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091289-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091289-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091289-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091289-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091289-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091289-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trospium Chloride	TROSPIUM CHLORIDE	Golden State Medical Supply, Inc.	8e5e2b3a-467b-4312-9778-8ff2ce938838	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091289 application number: ANDA091289 ndc (product): 60429-098
Trospium Chloride	TROSPIUM CHLORIDE	Actavis Pharma, Inc.	8b8d434c-daa2-4bf2-bde6-3e59f81bd88b	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091289 application number: ANDA091289 ndc (product): 0591-3636

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3636	Trospium Chloride	Trospium Chloride	Actavis Pharma, Inc.	ANDA	Current
60429-098	Trospium Chloride	Trospium Chloride	Golden State Medical Supply, Inc.	ANDA	Current
68001-228	Trospium Chloride	Trospium Chloride	BluePoint Laboratories	ANDA	Current
68001-228	Trospium Chloride	Trospium Chloride	BluePoint Laboratories	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9331	ORIG	2012-10-15